EUCTR2018-000746-19-PL进行中（未招募）1 期
An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials - ECZTEND
EO Pharma A/S0 个研究点目标入组 1,600 人开始时间: 2019年2月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Signed and dated informed consent has been obtained prior to any protocol-related procedures. Signed and dated informed consent for adolescent subjects must be provided by the subject’s legal representative(s) and by the subject in the form of a signed and dated informed assent (as applicable according to national laws or regulations).
- •-Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, or-1343, -1346, or TRA-WEI-0015-I.
- •-Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- •-Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
- •-Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline,
- •-Female subjects of childbearing potential (defined as Tanner stage =3 or menarche)* must use a highly effective** form of birth control (confirmed by the investigator) continuously for at least 1 month prior to the pregnancy test at baseline (Week 0), throughout the trial, and for at least 16 weeks (5 half lives of the IMP) after the last administration of IMP.
- •* A female subject is defined as not being of childbearing potential if she is:
- •Postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
- •Premenarchal.
- •**A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), same-sex partner, or vasectomised partner (given that the subject is monogamous).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •-Any condition that required permanent discontinuation of trial treatment in the parent trial.
- •-More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial
- •(to be assessed at baseline).
- •-Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the
- •investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable
- •safety risk for the subject.
- •-Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and
- •led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with
- •tralokinumab may present an unreasonable safety risk for the subject.
- •-Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 5 half-lives prior to baseline.
- •-Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
- •-Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational
- •biologic agents:
- •o Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
- •o Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- •-Clinically significant infection within 4 weeks prior to baseline.
- •-A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
- •-Tuberculosis requiring treatment within 12 months prior to screening.
- •- Known primary immunodeficiency disorder,
- •-Current participation in any other interventional clinical trial, except for tralokinumab trials LP0162-1325, -1326, -1334, -1339, -1341, -1342, or -1346, -1343, or TRA-WEI-0015-I.
- •-History of subject or subject’s legal representative(s) of chronic alcohol or drug abuse within 12 months prior to screening, or any condition (e.g., psychotic state, language barrier or other) associated with poor compliance, as judged by the investigator.
- •-Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody* (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb are eligible provided they are vaccinated against hepatitis B and have negative HBsAg and HBcAb.
- •*Subjects from the parent trial LP0162-1343 with a positive HBsAb may be randomised provided they have negative HBsAg, HBcAb, and HCV serology at screening.
研究者
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